(32 days)
Not Found
No
The document describes a laser imager for printing medical images and does not mention any AI or ML capabilities.
No
The device is a laser imager for printing medical images, not for treating patients.
No
The device is a dry laser imager that receives image data from diagnostic equipment and prints them on medical dry-film. It is not used to diagnose or detect anything.
No
The device description explicitly lists multiple hardware components (film supplying unit, film transferring unit, exposing unit, heat-developing unit, operating unit, power supplying unit, main control unit) and describes it as a "Laser Imager" that prints on "medical dry-film," indicating it is a physical hardware device.
Based on the provided information, the Dry Laser Imager, DRYPRO Model 832 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- DRYPRO Model 832 Function: The DRYPRO Model 832's intended use is to print image data received from diagnostic equipment (like CT, MRI, DSA) onto medical dry-film. It is essentially a printer for medical images.
- No Specimen Handling: The device description explicitly states it has "no patient contacting materials" and its function is solely related to processing and outputting image data, not analyzing biological specimens.
Therefore, the DRYPRO Model 832 falls under the category of a medical imaging accessory or output device, not an IVD.
N/A
Intended Use / Indications for Use
The Dry Laser Imager, DRYPRO Model 832 is intended to be used to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The output image is not a high resolution and DRYPRO Model 832 is not intended for use with FFDM systems.
Product codes
LMC
Device Description
The Dry Laser Imager, DRYPRO Model 832 is a Laser Imager to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film.
The device consists of film supplying unit, film transferring unit, exposing unit, heat-developing unit, operating unit, power supplying unit and main control unit.
This product employs semiconductor laser scanning, but it complies with the Federal Performance Standard 21 CFR Part 1040.10.
This device has no patient contacting materials and is intended to be used by trained personnel only.
The output of the device is evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention in case of malfunction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, DSA and other medical devices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel only.
The device is intended for the use at the X-ray department of the hospital, etc.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Ka61999
as required by 807.92
1. Company Identification
AUG 1 5 2006
Konica Minolta Medical & Graphic, Inc. 2970 Ishikawa-machi, Hachioji-shi, Tokyo 192-8505, Japan Tel : 81-426-60-9607 Fax: 81-426-60-9588
2. Official Correspondent
Kouji Matsushima (Mr.) Manager Advanced Technology Division R&D Center
3. Date of Submission
July 10, 2006
4. Establishment Registration No.
3003769120
5. Device Trade Name
Dry Laser Imager, DRYPRO Model 832
6. Common Name
Medical Image Hardcopy Device
7. Classification
Class II, 21 CFR 892. 2040, Medical image hardcopy device
8. Product Cord 90 LMC
2 - 1
1
9. Predicate Device
Konica Laser Imager, DRYPRO Model 771, 510(K) No.: K032681 Comparison of the principal characteristics of the two devices which are pertinent to Specification performance is attached.
10. Description of Device
The Dry Laser Imager, DRYPRO Model 832 is a Laser Imager to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film.
The device consists of film supplying unit, film transferring unit, exposing unit, heat-developing unit, operating unit, power supplying unit and main control unit.
This product employs semiconductor laser scanning, but it complies with the Federal Performance Standard 21 CFR Part 1040.10.
This device has no patient contacting materials and is intended to be used by trained personnel only.
The output of the device is evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention in case of malfunction.
11. Intended Use
The Dry Laser Imager, DRYPRO Model 832 is intended to be used to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The output image is not a high resolution and DRYPRO Model 832 is not intended for use with FFDM systems.
12. Compliance Standard
UL60601-1, UL-825-1 IEC60601-1, IEC60601-1-2, IEC60825-1, 21 CFR 1040.10, DICOM
2
| Item | Approved Medical Device | Medical Device Applied for Approval | |||
|---|---|---|---|---|---|
| Applicant,etc. | |||||
| Company | Konica Minolta Medical&Graphic Inc. | Konica Minolta Medical&Graphic Inc. | |||
| Product Name | DRYPRO model 771 | DRYPRO model 832 | |||
| Approval No. | K032681 | ||||
| Configuration | The device consists of film supplying unit and film | ||||
| transferring unit and exposing unit and heat-developing unit | The device consists of film supplying unit and film | ||||
| transferring unit and exposing unit and heat-developing unit | |||||
| and operating unit and power supplying unit and main control unit | and operating unit and power supplying unit and main control unit | ||||
| Principle | Select the printing format on the contoroller. | Select the printing format on the contoroller. | |||
| of Operation | Push the storing key in order to store the printing images | Push the storing key in order to store the printing images | |||
| and push the printing key. | |||||
| So the film is picked up and then is transferred exposing unit. | and push the printing key. | ||||
| So the film is picked up and then is transferred exposing unit. | |||||
| This printing images is exposed on that film there by laser and | This printing images is exposed on that film there by laser and | ||||
| optical devices. | optical devices. | ||||
| Exposed film is transferred to heat-developing unit and | Exposed film is transferred to heat-developing unit and | ||||
| photo-finished, then ejected from | photo-finished, then ejected from | ||||
| Specification | |||||
| Laser Source | Laser Diode [LD] (810nm) | Laser Diode [LD] (785nm) | |||
| Laser Power | 100mW (Maximum Output) | 240mW (Maximum Output) | |||
| Laser Modulator | Direct driving modulater | Direct driving modulater | |||
| Film Type | Konica Medical Imaging Film (SD-P & SD-Pc) | Konica Medical Imaging Film (SD-P & SD-Pc) | |||
| Film Sizes | 14"x 17",14"x 14",11"x 14" | 14"x 17",14"x 14",11"x 14",10"x 12",8"x 10" | |||
| Film Supply | 1 units | 1 unit or | |||
| 2 units (125 or 50 film on each) for installation of Optional Supply | |||||
| Interface | 10/100base-TX, 4network ports maxmum | 10/100/1000base-TX, 4network ports maxmum | |||
| Protocol | Digital Imaging and Communications in Medicine | Digital Imaging and Communications in Medicine | |||
| [DICOM] version 3.0 | [DICOM] version 3.0 | ||||
| Print service class | Print service class | ||||
| Image Data Storage | one Hard Disk Drive | outside PC | |||
| Image Formatting | 1,2,4,6,9,12,15,16,20,24,25,30,35,36,42, and 48 | 1,2,4,6,9,12,15,16,20,24,25,30,35,36,42, and 48 | |||
| frame formats, and mixed formats available. | frame formats, and mixed formats available. | ||||
| (Possible formats limited according to the image data) | (Possible formats limited according to the image data | ||||
| Pixel Size | 78.6 micro-meters minimum | 78.6 micro-meters minimum | |||
| Density Resolution | 14bits / pixel | 14bits / pixel | |||
| Cycle Time | 30 sec. | 40 sec. | |||
| Test Pattern | Pre-programmed SMPTE pattern | Pre-programmed SMPTE pattern | |||
| Smoothing | Choice of Pixel replication, Bi-linear. | Choice of Pixel replication, Bi-linear. | |||
| Spline functions via network | Spline functions via network | ||||
| Image Rotation | Choice of 0 (normal), 90 degrees via network | Choice of 0 (normal), 90 degrees via network | |||
| Exposure Setting | 8 types / port via network | 8 types / port via network | |||
| Image Borders | Choice of black or clear via network | Choice of black or clear via network | |||
| Image Framing | Choice of framing or no framing via network | Choice of framing or no framing via network | |||
| Print Developing | Choice between negative and positive printing | Choice between negative and positive printing | |||
| via network | via network | ||||
| Character Input | Data and message data printed in margins via | Data and message data printed in margins via | |||
| network | network | ||||
| Copying | 99 copies per print maximum via network | 99 copies per print maximum via network | |||
| Controller Display | Backlight liquid-crystal display (20places, 2lines) | Backlight liquid-crystal display (20places, 2lines) | |||
| External Dimensions | W630mm x D600mm x H1125mm | W599mm x D585mm x H570mm | |||
| Weight | Approx. 175Kg | Approx. 95Kg | |||
| Power Source | AC100 | AC100 | |||
| Power Consumption | 1020VA maximum | ||||
| (destination of USA) | 1200VA maximum (destination of USA) | ||||
| Work Space Environment | 15 | 15 | |||
| Magnetic Resistance | Up to 5 gauss | Up to 5 gauss | |||
| Exhaust Heat | Approx. 950kJ / hour | Approx. 1200kJ / hour | |||
| Optional Equipment | Warranty | 12months from the time of installation | 1bin Supply | 12months from the time of installation | |
| Purpose of use | The device is intended for the use at the X-ray | ||||
| department of the hospital, etc. the device that will | |||||
| acquire data from diagnostic equipment and then | |||||
| print the data onto laser imaging film. | The device is intended for the use at the X-ray | ||||
| department of the hospital, etc. the device that will | |||||
| acquire data from diagnostic equipment and then | |||||
| print the data onto laser imaging film. |
.
:
--- ··
2 - 3
3
Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person embracing another person. The seal appears to be a logo or emblem representing the U.S. Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 1 5 2006
Mr. Koji Matsushima Manager Konica Minolta Medical & Graphic, Inc. TSG, Advanced Technology Division, R&D Center 2970 Ishikawa-machi, Hachioji-Shi, Tokyo, 192-8505 JAPAN
Re: K061999
Trade/Device Name: Dry Laser Imager, DRYPRO Model 832 Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: July 10, 2006 Received: July 14, 2006
Dear Mr. Matsushima:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval}, it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "FDA" in a large, bold font. Below the letters, the word "Centennial" is written in a smaller font. Three stars are arranged in a horizontal line below the word "Centennial". The entire design is enclosed within a dotted circle.
Protecting and Promoting Public Health
4
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K061999 510(k) Number (if known)
Device Name
Indications for Use:
The Dry Laser Imager, DRYPRO Model 832 is intended to be used to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The output image is not a high resolution and DRYPRO Model 832 is not intended for use with FFDM systems.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061999
Page 1 of